Pandemic Influenza A/H1N1

Seal for Marking of Important Safety Information

In case of sending Dear Healthcare Professional Letters containing important safety information, which are prepared in collaboration with HALMED, marketing authorisation holders should place a seal prepared by HALMED on the front side of an envelope. Its purpose is to additionally emphasize the importance of information in the envelope.

Submission of Application Documentation for Assessment of Non-Interventional Trials

Submission of Safety Information in Clinical Trials of Medicinal Products

New Safety Information

Risk minimisation measures (RMM)

This page contains an overview of medicinal products with Risk Minimisation Measures (RMM) granted by HALMED. RMMs are additional measures introduced for certain medicines, the application of which is associated with specific risks - therefore they cannot be authorised without such measures.

List of serious adverse reactions

On this page you can access the list of adverse reactions considered to be serious, but are not unambiguously determined according to the seriousness criteria stipulated in Guideline on Good Pharmacovigilance Practices (GVP) Module VI, as well as inclusion and exclusion criteria for this list.